Trial · NCT05411900
BotulInum Toxin Type A for Peripheral Neuropathic Pain in subjEcts With Carpal Tunnel Syndrome
NCT05411900, Phase 2, Unknown, Francesco Bono
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. BotulInum Toxin Type A for Peripheral Neuropathic Pain in subjEcts With Carpal Tunnel Syndrome. Trials, record NCT05411900. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05411900
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BotulInum Toxin Type A for Peripheral Neuropathic Pain in subjEcts With Carpal Tunnel Syndrome
- NCT number
- NCT05411900
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 164 participants, estimated
- Lead sponsor
- Francesco Bono
- Conditions
- Carpal Tunnel Syndrome, Neurogenic Inflammation, Pain, Drug Use, Neuropathic Pain
- Interventions
- BoNT-A, Placebo
- First posted
- 2022-06-09
- Last updated
- 2022-06-09
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of two successive administrations of several injections of BoNT-A, compared with placebo by NRS | 25 weeks | The primary outcome is mesured as: -Change in mean weekly self-reported average daily pain intensity (mean pain over the past 24 hours recorded every morning in patient's diary during a week) measured by the 11-point numerical rating scale (NRS, 0=no pain, 10=maximum pain imaginable) of the brief pain inventory (BPI) from baseline (one week before randomisation) to 24 weeks after the first administration. |
| Primary | Efficacy of two successive administrations of several injections of BoNT-A, compared with placebo by NRS | 25 weeks | The primary outcome is mesured as: \- Change in weekly self-reported maximum daily pain intensity (maximum pain intensity over the past 24 hours recorded every morning in patient's diary) measured by the 11-point NRS (NRS, 0=no pain, 10=maximum pain imaginable) of the BPI from baseline (1 week before randomisation) to 24 weeks after the first administration. |
| Secondary | Assessment of the therapeutic gain of BoNT-A in terms of relief of spontaneous pain | 25 weeks | Therapeutic gain of the second administration of BoNT-A in terms of relief of spontaneous pain, measured as change in mean weekly average daily pain intensity, measured by the 11-point numerical rating scale (NRS, 0=no pain, 10=maximum pain imaginable) of the BPI , and change in maximum pain in subjects who received two administrations. |
| Secondary | Assessment of BoNT-A effects in reducing neuropathic symptoms with Bedside Sensory Assessment. | 25 weeks | Effects of BoNT-A on \- sensory disturbances and hyperalgesia in response to mechanical punctate and thermal stimuli measured by sensory assessment at the bed side; The subject examined at the bed side describes the sensation after a precise and reproducible stimulus is applied. To assess either a loss (negative sensory signs) or a gain (positive sensory signs) of somatosensory function, the responses are graded as normal, decreased or increased. The stimulus evoked (positive) pain types are classified as hyperalgesic (experiencing increased pain from a stimulus that is normally perceived as less painful) or allodynic (experiencing pain from a stimulus that does not normally trigger a pain response), and according to the dynamic or static character of the stimulus. |
| Secondary | Assessment of BoNT-A effects in reducing neuropathic symptoms with VAS. | 25 weeks | Effects of BoNT-A on \- severity of brush-induced allodynia measured by a brush on the Visual Analogue Scale, a self-reported scale consisting of a horizontal or vertical line, usually 10 centimetres long (100 mm) anchored at the extremes by two verbal descriptors referring to the pain status. |
| Secondary | Assessment of BoNT-A effects in reducing neuropathic symptoms with the Neuropathic Pain Symptom Inventory . | 25 weeks | Effects of BoNT-A on \- neuropathic symptoms (ie, burning pain, deep pain, paroxysmal pain, paraesthesia or dysaesthesia, and allodynia) measured with the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire rates the intensity of five neuropathic dimensions (symptom combinations) during the last 24 hours (burning, deep pain, paroxysmal pain, allodynia/hyperalgesia, paresthesia/dysesthesia) on an 11-point (0-10) numerical scale. |
| Secondary | Assessment of BoNT-A impact on patient's quality of life. | 25 weeks | Impact of BoNT-A treatment on patient's quality of life, measured through Visual Analogue Scale of the 5-level EuroQoL (EQ-5D-5L) from 0 (imaginable health state) to 100 (worst imaginable health state) at baseline and after 24 weeks. |
| Secondary | Assessment of BoNT-A safety | 24 weeks | BoNT-A's overall safety and tolerability will be assessed throughout the study by measuring the occurrence and grade of AEs or serious AEs (SAEs), both registered by the subject in the patient diary or assessed by the physician during the visit(s). All AEs will be identified using MedDRA terms and will be evaluated for intensity and correlation with treatment |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers17
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05411900
GET https://conductscience.org/api/trials/v1/NCT05411900/registered